10724. DEVICE MASTER RECORD

10724 DEVICE MASTER RECORD 10724.1 Each manufacturer shall maintain device master records (DMR). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with § 10706. The DMR for each type of device shall include, or refer to the location of, the following information: (a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications; (b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications; (c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used; (d) Packaging and labeling specifications, including methods and processes used; and (e) Installation, maintenance, and servicing procedures and methods. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10724